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Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)

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ClinicalTrials.gov Identifier: NCT00581958
Recruitment Status : Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Georgetown University
National Institute of Standards and Technology
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.

Condition or disease Intervention/treatment
Cancer Other: Blood Samples

Detailed Description:
MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.

Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)
Actual Study Start Date : November 2007
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
Patients undergoing HSCT
Research subjects will have blood and/or urine sampled at three time points in the Department of Radiation Oncology. Participating patients will have at least a total two samples collected at each time point. The first sampling will occur before the first TBI treatment is given. The second sampling will occur before the second TBI treatment, usually 3 to 8 hours after the first treatment (in the case of multifraction TBI). If a patient is being treated with single fraction TBI, then the second sampling will occur approximately 3-8 hours after the first TBI treatment. The third and final sampling will occur at the next morning blood draw, prior to the fourth TBI treatment (in the case of multifraction TBI), 24 hours after the first TBI treatment.
Other: Blood Samples
blood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.



Primary Outcome Measures :
  1. To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays. [ Time Frame: 3 years ]
    The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.


Biospecimen Retention:   Samples Without DNA
Blood and Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential research subjects will be identified by the primary Radiation Oncologist whom the patient is referred to by the Adult or Pediatric Bone Marrow Transplant Service.
Criteria

Inclusion Criteria:

  • Patients greater than 4 years of age at Memorial Sloan-Kettering Cancer Center
  • Must be undergoing hematopoietic stem cell transplantation (either autologous or allogenic) in conjunction with a conditioning regimen that includes TBI (single or multiple fraction)
  • Functional central venous catheter

Exclusion Criteria:

  • No subjects will be excluded from the proposed research study for demographic reasons. Treatment with growth factors, such as keratinocyte growth factor (KGF), will not be grounds for exclusion.
  • Subjects who will receive radiation therapy within 5 days prior to TBI will be excluded.
  • Subjects who will receive systemic antineoplastic chemotherapy within 7 days prior to TBI not have research bloods collected. Only urine will be collected from these patients.
  • Based on current knowledge, we will not a priori exclude patients based on disease status (ie, patients in or out of remission will be included in this study), type of disease(ie, chromosomal breakage syndromes), or previous therapies (unless exclusion criteria is met).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581958


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Georgetown University
National Institute of Standards and Technology
Investigators
Principal Investigator: Christopher Barker, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581958     History of Changes
Obsolete Identifiers: NCT00899886
Other Study ID Numbers: 07-158
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
total body irradiation
Cancer
Hematopoietic System